AnesthesiaIVFNCT03814330
A Comparison of Sedation/Analgesia & LMA on Anxiety Level and Patient Satisfaction in In-Vitro Fertilization
A study testing State-Trait Anxiety Inventory, Quality of Recovery Score and Sedation/Analgesia in people with Anesthesia and In-vitro Fertilization, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted reproduction technique is usually required during oocyte removal, which is one of the basic steps throughout the entire procedure. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, In-vitro Fertilization, Analgesia
- What is being tested?
- State-Trait Anxiety Inventory, Quality of Recovery Score and Sedation/Analgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2019to 21 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiology (ASA) scores of I-II
- Aged 18-55 years old
Who cannot join
- American Society of Anesthesiology (ASA) scores of III-IV
- Under 18 years of age
- Over 55 years of age,
- Uncontrolled diabetes mellitus, cardiovascular, pulmonary disease, cerebrovascular events,
- Patients with an allergy to anesthetic drugs
- Pregnants
- Patients who refused informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two Different Anesthetic Application (Sedation / Analgesia & LMA) on Anxiety Level and Patient Satisfaction in Patients With in Vitro Fertilization: Prospective Randomized Clinical Trial
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted reproduction technique is usually required during oocyte removal, which is one of the basic steps throughout the entire procedure. Until now, different anesthetic techniques such as conscious sedation, general anesthesia and regional anesthesia have been tried, no superiority has been proved against each other. The main point of anesthesia management in IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and fertilization.
The aim of this prospective randomized clinical trial was to compare two different anesthesia applications (sedation \& laryngeal mask airway) on anxiety and patient satisfaction in patients with IVF.
Read the detailed description
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted reproduction technique is usually required during oocyte removal, which is one of the basic steps throughout the entire procedure. Until now, different anesthetic techniques such as conscious sedation, general anesthesia and regional anesthesia have been tried, no superiority has been proved against each other. The main point of anesthesia management in IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and fertilization.
IVF requires the collection of mature oocytes from the ovaries of infertile patients. These oocytes are then fertilized in vitro and allowed to become embryos. Afterwards, these embryos are transferred into the uterus of the patients. Ultrasonography-guided transvaginal aspiration makes oocyte intake less invasive compared to prior techniques and can be administered within 30 minutes. With the development of this method, trauma was minimalized and side effects were reduced. However, the possible effects of different anesthetics on oocytes are still being discussed. The potential side effects of different anesthesia applications have been observed not only in patients receiving oocytes, but also in embryo development and pregnancy success due to the quality of oocytes. The pain of patients is common after the puncture of the vaginal fornix. It is usually defined as deep menstrual pain, quickly disappears and leaves a mild abdominal pain. Therefore, the anesthetist should perform adequate pain relief to immobilize the patient to avoid the risk of perforating the vessels during the procedure. Another challenge for the anesthesiologist is to alleviate the increased anxiety associated with social and psychological stress associated with IVF.
Anxiety may develop before and after the procedure, especially in patients undergoing oocyte collection. The patient's anxiety is usually present before entering the operating room. The assessment, which was started to be developped by investigators, was aimed to measure state anxiety levels in normal and non-normal individuals. State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement.
Patient satisfaction depends on the patient's expectations and the benefits expected by the patients with the service they receive. Patient satisfaction is the result of meeting the wishes and expectations of the patients. An investigator has developed the Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200. No special training is required for the implementation of the survey. The fact that the patient can perform the survey on his own and can be done in a short time gives a significant advantage.
The aim of this prospective randomized clinical trial was to compare two different anesthesia applications (sedation \& laryngeal mask airway) on anxiety and patient satisfaction in patients with IVF.
- Conditions
- Anesthesia, In-vitro Fertilization, Analgesia
- Being tested
- State-Trait Anxiety Inventory, Quality of Recovery Score, Sedation/Analgesia, Laryngeal Mask Airway
- Keywords
- Anesthesia management, In-vitro Fertilization, Sedation-Analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State-Trait Anxiety InventoryDiagnostic test
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. State-Trait Anxiety Inventory determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement
Quality of Recovery ScoreDiagnostic test
Also called Recovery Quality Score-40
Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.
Sedation/AnalgesiaOther
Patients will be performed the procedure with sedation/analgesia under the condition of spontaneous breathing.
Laryngeal Mask AirwayDevice
Patients will be performed the procedure with Laryngeal Mask Airway during the procedure. Laryngeal Mask Airway is a supraglottic airway device to ventilate the patients during anesthetic procedure.
| Study group | Role | What they receive |
|---|---|---|
| Sedation/Analgesia | Placebo comparator | Patients with applied sedation analgesia will perform State-Trait Anxiety Inventory and Quality of Recovery Score Receives: Diagnostic Test: State-Trait Anxiety Inventory; Diagnostic Test: Quality of Recovery Score; Other: Sedation/Analgesia |
| Laryngeal Mask Airway | Active comparator | Patients with applied Laryngeal Mask Airway will perform State-Trait Anxiety Inventory and Quality of Recovery Score Receives: Diagnostic Test: State-Trait Anxiety Inventory; Diagnostic Test: Quality of Recovery Score; Device: Laryngeal Mask Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
Measured: State-Trait Anxiety Inventory will be performed to the all patients 2 hours before the IVF procedure.
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
Measured: State-Trait Anxiety Inventory will be performed to the all patients 4 hours after the IVF procedure.
Quality of Recovery Score
Quality of Recovery Score is a global measure of quality of recovery. It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. Quality of Recovery Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). This consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.
Measured: Quality of Recovery Score will be performed to the all patients 24 hours after the IVF procedure
Secondary outcomes (3)
Heart rate
Heart rate is measured as beats/minute on the anesthesia monitor
Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
Mean arterial pressure is measured as mmHg on the anesthesia monitor
Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor
Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start24 Jan 2019
- Primary completion21 May 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sedat AKBAS, Inonu University
- Investigators
- Sedat Akbas, Asst. Prof., Study director, Inonu University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814330
- Sponsor's protocol ID
- sedatakbas5
- Acronym
- IVF
- Status last verified
- Aug 2019
- First submitted
- 4 Jan 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piroli A, Marci R, Marinangeli F, Paladini A, Di Emidio G, Giovanni Artini P, Caserta D, Tatone C. Comparison of different anaesthetic methodologies for sedation during in vitro fertilization procedures: effects on patient physiology and oocyte competence. Gynecol Endocrinol. 2012 Oct;28(10):796-9. doi: 10.3109/09513590.2012.664193. Epub 2012 Mar 16.
PubMed 22420562
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Different Anesthetic Application (Sedation / Analgesia & LMA) on Anxiety Level and Patient Satisfaction in Patients With in Vitro Fertilization: Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03814330
- Acronym / sponsor ID
- IVF / sedatakbas5
- Conditions
- Anesthesia, In-vitro Fertilization, Analgesia
- Keywords
- Anesthesia management, In-vitro Fertilization, Sedation-Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted reproduction technique is usually required during oocyte removal, which is one of the basic steps throughout the entire procedure. Until now, different anesthetic techniques such as conscious sedation, general anesthesia and regional anesthesia have been tried, no superiority has been proved against each other. The main point of anesthesia management in IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and fertilization.
The aim of this prospective randomized clinical trial was to compare two different anesthesia applications (sedation \& laryngeal mask airway) on anxiety and patient satisfaction in patients with IVF.
Detailed description
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted reproduction technique is usually required during oocyte removal, which is one of the basic steps throughout the entire procedure. Until now, different anesthetic techniques such as conscious sedation, general anesthesia and regional anesthesia have been tried, no superiority has been proved against each other. The main point of anesthesia management in IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and fertilization.
IVF requires the collection of mature oocytes from the ovaries of infertile patients. These oocytes are then fertilized in vitro and allowed to become embryos. Afterwards, these embryos are transferred into the uterus of the patients. Ultrasonography-guided transvaginal aspiration makes oocyte intake less invasive compared to prior techniques and can be administered within 30 minutes. With the development of this method, trauma was minimalized and side effects were reduced. However, the possible effects of different anesthetics on oocytes are still being discussed. The potential side effects of different anesthesia applications have been observed not only in patients receiving oocytes, but also in embryo development and pregnancy success due to the quality of oocytes. The pain of patients is common after the puncture of the vaginal fornix. It is usually defined as deep menstrual pain, quickly disappears and leaves a mild abdominal pain. Therefore, the anesthetist should perform adequate pain relief to immobilize the patient to avoid the risk of perforating the vessels during the procedure. Another challenge for the anesthesiologist is to alleviate the increased anxiety associated with social and psychological stress associated with IVF.
Anxiety may develop before and after the procedure, especially in patients undergoing oocyte collection. The patient's anxiety is usually present before entering the operating room. The assessment, which was started to be developped by investigators, was aimed to measure state anxiety levels in normal and non-normal individuals. State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement.
Patient satisfaction depends on the patient's expectations and the benefits expected by the patients with the service they receive. Patient satisfaction is the result of meeting the wishes and expectations of the patients. An investigator has developed the Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200. No special training is required for the implementation of the survey. The fact that the patient can perform the survey on his own and can be done in a short time gives a significant advantage.
The aim of this prospective randomized clinical trial was to compare two different anesthesia applications (sedation \& laryngeal mask airway) on anxiety and patient satisfaction in patients with IVF.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Sedation/Analgesia | Placebo comparator | Diagnostic Test: State-Trait Anxiety Inventory, Diagnostic Test: Quality of Recovery Score, Other: Sedation/AnalgesiaPatients with applied sedation analgesia will perform State-Trait Anxiety Inventory and Quality of Recovery Score |
| Laryngeal Mask Airway | Active comparator | Diagnostic Test: State-Trait Anxiety Inventory, Diagnostic Test: Quality of Recovery Score, Device: Laryngeal Mask AirwayPatients with applied Laryngeal Mask Airway will perform State-Trait Anxiety Inventory and Quality of Recovery Score |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) scores of I-II
- Aged 18-55 years old
Key exclusion criteria (7 listed)
- American Society of Anesthesiology (ASA) scores of III-IV
- Under 18 years of age
- Over 55 years of age,
- Uncontrolled diabetes mellitus, cardiovascular, pulmonary disease, cerebrovascular events,
- Patients with an allergy to anesthetic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| State-Trait Anxiety InventoryState-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. State-Trait Anxiety Inventory determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement | Diagnostic test | Laryngeal Mask Airway, Sedation/Analgesia |
| Quality of Recovery ScoreAlso: Recovery Quality Score-40Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200. | Diagnostic test | Laryngeal Mask Airway, Sedation/Analgesia |
| Sedation/AnalgesiaPatients will be performed the procedure with sedation/analgesia under the condition of spontaneous breathing. | Other | Sedation/Analgesia |
| Laryngeal Mask AirwayPatients will be performed the procedure with Laryngeal Mask Airway during the procedure. Laryngeal Mask Airway is a supraglottic airway device to ventilate the patients during anesthetic procedure. | Device | Laryngeal Mask Airway |
Primary outcome
State-Trait Anxiety Inventory
Time frame: State-Trait Anxiety Inventory will be performed to the all patients 2 hours before the IVF procedure.
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
State-Trait Anxiety Inventory
Time frame: State-Trait Anxiety Inventory will be performed to the all patients 4 hours after the IVF procedure.
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
Quality of Recovery Score
Time frame: Quality of Recovery Score will be performed to the all patients 24 hours after the IVF procedure
Quality of Recovery Score is a global measure of quality of recovery. It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. Quality of Recovery Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). This consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.
3 secondary outcomes
Heart rate
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Background: PubMed 22420562Piroli A, Marci R, Marinangeli F, Paladini A, Di Emidio G, Giovanni Artini P, Caserta D, Tatone C. Comparison of different anaesthetic methodologies for sedation during in vitro fertilization procedures: effects on patient physiology and oocyte competence. Gynecol Endocrinol. 2012 Oct;28(10):796-9. doi: 10.3109/09513590.2012.664193. Epub 2012 Mar 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sedat Akbas, Asst. Prof. study director
Inonu University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing State-Trait Anxiety Inventory, Quality of Recovery Score and Sedation/Analgesia in people with Anesthesia and In-vitro Fertilization, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: State-Trait Anxiety Inventory will be performed to the all patients 2 hours before the IVF procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03814330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.